Testing Protocol

The DTS-BGMS Surveillance Program was created to test the performance of cleared BG Monitoring systems and determine whether they are delivering acceptable levels of accuracy. The Program is run by a Steering Committee of experts in glucose monitoring. This Committee established a target level of acceptable accuracy, a protocol for testing a variety of BGMS with different outcome measures including: a set of statistics to describe the performance of each BGMS, a metric for assigning a seal of approval for acceptable performance on the testing procedure, and a reporting procedure for notifying patients, healthcare providers, payers, and the FDA the results of the testing process.

A Protocol for Testing BGM Systems

The testing protocol is the most accurate method of any current widely available method used for applying for regulatory clearance. Each BGMS (monitor and teststrips) are obtained by the Program from stores or mail-order houses so the manufacturer has no input in supplying products to be tested. The program uses a blinded method for testing the same blood samples on a BGMS and also on an accurate laboratory grade reference (comparative) instrument at a different location with accurate calibration methods. The two sets of results are compared afterwards for acceptable levels of BGMS performance. The investigators testing the blood on the BGMS see only one set of results but not the results of the comparison to the method. The results are plotted with a variety of statistical metrics. The data is posted on the DTS-BGMS Surveillance Program website and are also sent to the FDA. BGMS demonstrating acceptable performance are awarded a DTS Seal of Approval.

Testing BGMS Across a Wide Glucose Range

BGMS are used for measuring  blood glucose levels across a wide range, including normal levels, low levels, and high levels. A BGMS must demonstrate acceptable accuracy at all three levels to be considered as having acceptable performance. The DTS-BGMS Surveillance Program specifies that BG samples must be tested from each of these three levels. For some BGMS if too few subjects have low BG levels, then the blood sample will be manipulated to lower the glucose concentration. This method of manipulating the glucose levels is used by industry to test the performance of BGMS in the hypoglycemic range. The DTS-BGMS Surveillance Program will use a similar approach for some blood samples with BGMs whose function is expected to be acceptable with such manipulated blood samples. Acceptable performance of BG Monitors in the hypoglycemic range is importance because when a patient has low blood glucose it is important to accurately recognize this state in order to begin treatment on time and provide adequate treatment. 

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